Label: DIABETIC TUSSIN NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan hbr, and diphenhydramine hcl liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 17, 2019

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  • Active ingredients (in each 5 mL)

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Diphenhydramine HCl 12.5 mg

  • Purposes

    Pain Relief

    Cough Suppressant

    Antihistamine

  • Uses

    temporarily relieves common cold/flu symptoms including:

    •
    cough due to minor throat and bronchial irritation
    •
    sore throat
    •
    headache
    •
    minor aches and pains
    •
    muscular aches
    •
    fever
    •
    runny nose and sneezing
  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if

    •
    adults take more than 6 doses in 24 hours, which is the maximum daily amount
    •
    child takes more than 5 doses in 24 hours, which is the maximum daily amount
    •
    taken with other drugs containing acetaminophen
    •
    adult has 3 or more alcoholic drinks everyday while using this product

    Sore throat warning: If sore throat is severe, persists for more than two days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

    Do not use

    •
    with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    •
    if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
    •
    with any other product containing diphenhydramine, even one used on the skin

    Ask a doctor before use if you have

    •
    liver disease
    •
    glaucoma
    •
    a breathing problem such as emphysema or chronic bronchitis
    •
    trouble urinating due to enlargement of the prostate gland
    •
    cough that occurs with too much phlegm (mucus)
    •
    a chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

    Ask a doctor or pharmacist before use

    if the user is taking the blood thinning drug warfarin, tranquilizers or sedatives.

    When using this product:

    •
    you may get very drowsy
    •
    avoid alcoholic drinks
    •
    alcohol, sedatives and tranquilizers may increase drowsiness
    •
    be careful when driving a motor vehicle or operating machinery
    •
    excitability may occur, especially in small children

    Stop use and ask a doctor if

    •
    redness or swelling is present
    •
    fever gets worse or lasts more than 3 days
    •
    new symptoms occur
    •
    cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts

    These could be signs of a serious condition.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical even if you do not notice any signs or symptoms.

  • Directions

    •
    take every 4 to 6 hours
    •
    do not exceed more than 5 doses in 24 hours for children under 12 years of age
    •
    do not exceed more than 6 doses in 24 hours for adults and children over 12 years of age

    adults & children 12 years & over

    10 mL (2 teaspoonfuls)

    children 6 years to under 12 years

    5 mL (1 teaspoonful)

    children under 6 years

    ask a doctor
  • Other information

    •
    Phenylketonurics: contains phenylalanine 8.4 mg per teaspoonful (5 mL)
    •
    Store at room temperature 20-25°C (68-77°F)
  • Inactive ingredients

    Acesulfame potassium, aspartame, citric acid, hypromellose, menthol, methylparaben, natural & artificial orange flavor, polyethylene glycol, potassium sorbate, propylene glycol, purified water. Sodium citrate may be used to adjust pH.

  • Questions or comments?

    Call: 1-800-899-3116, Mon-Thurs 9:00 am - 5:00 pm EST, Fri 9:00 am - 2:30 pm EST.

    Serious side effects associated with use of this product may be reported to this number.

    Rev. 452:04 12/11

  • Package/Label Principal Display Panel

    Image of Carton - 118 mL

    NDC 61787-452-04

    Diabetic Tussin®

    DECONGESTANT FREE

    Nighttime

    Cold & Flu

    FEVER, HEADACHE

    BODY ACHES

    COUGHS

    SNEEZING

    RUNNY NOSE

    Liquid

    NO

    Sodium

    Sorbitol

    Fructose

    & Dyes

    ACETAMINOPHEN

    DEXTROMETHORPHAN HBr

    DIPHENHYDRAMINE HCl

    SAFE FOR DIABETICS

    SUGAR & ALCOHOL FREE!

    GLUTEN FREE

     

    4 FL OZ (118 mL)

     

     

  • INGREDIENTS AND APPEARANCE
    DIABETIC TUSSIN NIGHTTIME COLD AND FLU 
    acetaminophen, dextromethorphan hbr, and diphenhydramine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61787-452
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ASPARTAME (UNII: Z0H242BBR1)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    Product Characteristics
    ColorBROWN (clear, colorless to light brown) Score    
    ShapeSize
    FlavorORANGE (natural & artificial orange flavor) , MENTHOLImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61787-452-041 in 1 CARTON08/01/2010
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:61787-452-081 in 1 CARTON08/01/2010
    2237 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/01/2010
    Labeler - Health Care Products (101196749)
    Registrant - Hi-Tech Pharmacal Co., Inc. (101196749)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hi-Tech Pharmacal Co., Inc.101196749MANUFACTURE(61787-452)
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